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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Request, August 1, 2011 - Anascorp

 

From:        Ertel, Donald
Sent:          Monday, August 01, 2011 3:36 PM
To:             'Jennifer Spinella'; ----(b)(4)----
Cc:             Waites, Nancy; Fisher, Robert
Subject:     Information Request
 
Jennifer and (b)(4),
 
I have an information request in support of the review of:
 
STN 125355/0
Anascorp®, Centruroides (Scorpion) Immune F(ab')2 (Equine) Injection
 
  1. Is an AQL sampling for visual inspection being performed for the final container (vial) after the 100% visual inspection and prior to release? If so, what are your sample size and acceptance limits?
  2. Have you performed bioburden log reduction studies for the -----------------(b)(4)-------------- the lyophilizer? If so, per what protocol and what was the log reduction required?
    1. What --------(b)(4)-------- were studied? What contact time, temperature, and rinsing was required?
    2. How did you test for --------------(b)(4)---------------, and what was the acceptance limit?
  3. At what step in process is the sample taken for sterility testing for the Bulk? Is the sample taken directly from the bulk container?
 
I will follow-up with a phone call.
 
Don Ertel
 
__________________________________________________________________________________
__________________________________________________________________________________
 
Donald Ertel
Consumer Safety Officer
FDA/CBER/OCBQ/DMPQ
1401 Rockville Pike, HFM-675
Rockville, MD 20852-1448
Office: 301.827.7121
Fax: 301.827.3536